In the past 10 years, LLX has served over 40 clients with over 100 studies, from phase 1 to phase 4, and covering therapeutics areas such as oncology, neuroscience (CNS), autoimmune, heart diseases, lung diseases, Kidney disease, rare diseases, etc. as well as multiple ISS, ISE studies. LLX also helped multiple clients successfully submitted their studies to FDA (NDA and BLA), Health Canada and EMA (MAA).
LLX is always focusing on building collaborative, highly efficient, capable, quality team. With our Statistician and statistical programming team members, around 50 has PhD and master’s degree in biostatistics or statistics, 30 with public health or computer related masters or bachelor’s degree in biostatistics, epidemiology, biology and other discipline. Around 20% of statisticians/programmers have above 10 years experiences, 30% have above 5 years experiences, and 50% have 1-4 years experiences. Company provides comprehensive trainings on SOPs, CDISC and other technical skills to all related employees.
LLX fully implemented Quality Management System (QMS), which consists of Policies, SOPs and work instructions for Biostatistics, programming, IT and general. Our IT infrastructure is fully validated, Microsoft Azure hosted, encrypted environment. Clinical trial data is fully backed, and server is replicated for disaster recovery.
LLX is also working with partners and other service provides on EDC, clinical operations, PK/PD services and medical writing. These cooperation will take advantages of our partner’s expertise and bring more complete, high quality services to our clients.